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Ecotoxicological information

Short-term toxicity to fish

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Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
17 july 1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)
Version / remarks:
April 1996
Deviations:
no
Principles of method if other than guideline:
Description of the test procedure
Pre-Experiment
A preliminary test (static test) was performed at the saturation concentration (equivalent to 100 mg/L nominal concentration).
The test solution used in the preliminary test was prepared by mechanical dispersion. An amount of 0.2 g test item was dissolved in 2000 mL test medium (ISO medium) using approx. 10 min ultrasonic dispersion. This solution was shaken for about 1 hour and thereafter the non-dissolved test material was removed by filtration through a paper filter in order to give the saturated test solution (equivalent to 100 mg/L nominal concentration). The test solution was freshly prepared in the testing laboratory just before introduction of the test animals (start of the experiment).
Three fish were exposed to the test item treated and control group for 96 hours. No replicates were used. Both test vessels contained two litre test medium.
No mortality or any sub-lethal effects were noted in the treatment group or in the control group during the 96-h exposure period.

Test item concentrations in the Definitive Test
No test item effects were observed during the preliminary test. Therefore, a limit test was carried out with one treatment group at the saturation concentration (equivalent to 100 mg/L nominal concentration) and a concurrent control.

Performance of the Test
Body Weight Measurement and Introduction of Fish
At the start of the test (on day 0) 10 fish were introduced into each aquarium, each containing 5 litre testing solution. Before introduction of test animals, the body weight of fish was measured and recorded: first the weight of a vessel filled with water was determined. Then the 10 fish were selected randomly and placed into this vessel. The weight of the group of fish was registered and the average body weight calculated. On the basis of the above, the loading of the test-aquariums was calculated and were 0.475 g/L in the control and 0.458 g/L in the treatment group.

Observations
The fish were observed at approximately 3, 6, 24, 48, 72 and 96 hours after start of the test for signs of intoxication and mortality. Measurements of pH, dissolved oxygen and temperature were carried out daily (as described in section 5.5).

Body Length Measurement
The body length of each fish were measured at the end of the test in order to check their compliance with the size range recommended for the species by the test guideline (OECD No. 203). The measured values were within the range of 2.05-2.75 cm.

Analysis of Test Item Concentrations
On request of the Sponsor no determination of the test item concentration was performed during the study.
GLP compliance:
yes (incl. QA statement)
Vehicle:
yes
Remarks:
water
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
The reconstituted water (ISO medium) has an approximate theoretical total hardness of 249 mg/L (as CaCO3).
Test temperature:
The aquariums were kept in a temperature-controlled tray. The measured temperatures were within a range of 22.8 – 23.6 °C in the test aquariums (the maximum deviation did not exceed ± 1°C).
pH:
The test was carried out without adjustment of pH. The measured pH values were in the range of 7.48 – 7.74 during the test.
Dissolved oxygen:
Oxygen Concentration: The dissolved oxygen concentration was in the range of 83.0 – 96.6 % of the air saturation value at the temperature used. Test solutions were not aerated during the test.
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Key result
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Key result
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Key result
Duration:
96 h
Dose descriptor:
LOEC
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Key result
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Details on results:
No determination of the test item concentration was performed during the study; therefore the biological results are based on the nominal concentration.
Validity criteria fulfilled:
yes
Conclusions:
In this 96-hour static acute toxicity test on Zebrafish (Brachydanio rerio) the test item CENTELLA ASIATICA had no toxic effect on fish up to the solubility limit of the test item in the test medium (equivalent to 100 mg/L nominal concentration). The 96-h NOEC was determined to be 100 mg/L.

Description of key information

In a 96-hour static acute toxicity test on Zebrafish (Brachydanio rerio) the test item CENTELLA ASIATICA had no toxic effect on fish up to the solubility limit of the test item in the test medium (equivalent to 100 mg/L nominal concentration). The 96-h NOEC was determined to be 100 mg/L.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
100 mg/L

Additional information